The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1477-2017·Announced 2017-03-22

C2 CryoBalloon Controller Cap Recall Due to Cracking Risk

C2 Therapeutics is recalling 755 C2 CryoBalloon Controller Caps because they may crack when tightened, potentially compromising the device's integrity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device integrity) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

C2 Therapeutics, Inc. is recalling 755 units of the C2 CryoBalloon Ablation System Controller Cap (Model number: FG-1012). The affected component is the Controller Cap, which is provided to customers already assembled onto the Controller. The recall covers products distributed worldwide, including the United States, Germany, Belgium, The Netherlands, the United Kingdom, and China, between February 1, 2016, and February 8, 2017.

The recall was initiated because the Controller Cap may crack as it is tightened onto the controller. This cracking could compromise the integrity of the cap and result in damage to the component. The C2 CryoBalloon Ablation System is a cryosurgical tool intended for endoscopic applications, specifically for the ablation of Barrett's Esophagus with dysplasia.

Healthcare providers and facilities that have received these devices should stop using the affected Controller Caps and contact C2 Therapeutics for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number…
Manufacturer
C2 Therapeutics, Inc.
Category
Medical Device — Cryosurgical Device
Hazard
Affected units
755

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All lots distributed between June 23
  • 2016 and December 20
  • 06242016-01 1-Jan-2017
  • 11282016-03 2-Jun-2017
  • 01042016-03 14-Jul-16
  • 06292016-02 6-Jan-2017
  • 09202016-01 21-Mar-2017
  • 07062016-01 8-Jan-2017
  • 09222016-01 23-Mar-2017
  • 01252016-02 02-Aug-16
  • 07082016-02 13-Jan 2017
  • 09232016-01 28-Mar-2017
  • 01282016-01 01-Aug-16
  • 07082016-03 14-Jan-2017
  • 09232016-02 27-Mar-2017
  • 01292016-01 02-Aug-16
  • 07152016-01 21-Jan-2017
  • 09292016-01 4-Apr-2017
  • 02022016-03 09-Aug-16
  • 07152016-02 20-Jan-2017

Distribution

Distributed nationwide across the United States.

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