MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES

Model Number	FG 1012/ FG 1009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Stenosis (2263)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stricture reported by the physician as definitely procedure-related, and possibly device-related.Stricture (narrowing of the esophagus) is a known potential adverse event in endoscopic ablation therapy, and may occur regardless of whether or not there is a device malfunction.Patient symptoms resolved after standard therapeutic intervention (tts balloon dilation).
Event or Problem Description
C2 therapeutics became aware of stricture event on (b)(6) 2017.Patient was treated with the cryoballoon ablation system on (b)(6) 2017.On (b)(6) 2017 patient experienced dysphagia.On (b)(6) 2017 patient notified nurse practitioner of the dysphagia and a stricture was noticed upon examination.On (b)(6) 2017 patient had stricture dilated.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, ste 1; redwood city CA 94063
• MDR Report Key: 6959838
• Report Number: 3008780134-2017-00016
• Device Sequence Number: 1141501
• Product Code: GEH
• UDI-Device Identifier: 00854924006125
• UDI-Public: 00854924006125
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 01/12/2018
• Device Model Number: FG 1012/ FG 1009
• Device Lot Number: 07112017-01/02142017-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention