MAUDE Adverse Event Report: C2 THERAPEUTICS CRYOBALLOON ABLATION SYSTEM; CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH

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	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dysphagia is a known, anticipated adverse event after endoscopic eradication therapy, and may occur after radiofrequency ablation or cryotherapy procedures.During the egd to examine the symptoms of dysphagia, a narrowing of the esophagus was noted; however, the endoscope was passed through the narrowed area and further dilation was not required.
Event or Problem Description
C2 became aware of dysphagia event on (b)(6) 2017.The patient was initially treated with the cryoballoon on (b)(6) 2017.At a 30-day phone call follow up, the patient reported difficulty swallowing and food getting stuck in the esophagus (on (b)(6) 2017), but eventually went down.The patient was scheduled for egd on (b)(6) 2017 with a possible dilation to address the dysphagia.A narrowed area in the esophagus was noted; the endoscope was passed through the area of narrowing and no further dilation was performed.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Common Device Name: CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way, ste 1; redwood city CA 94063
• MDR Report Key: 6904987
• Report Number: 3008780134-2017-00014
• Device Sequence Number: 16368351
• 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): 09/08/2017

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: 02/01/2017
• Device Model Number: FG 1012/FG 1009
• Device Lot Number: 08012017-01/12052016-02
• 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: 09/08/2017
• Initial Report FDA Received Date: 09/29/2017
• 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