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

Model Number FG 1012

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Vomiting (2144); Stenosis (2263)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Stricture requiring treatment is an anticipated adverse after endoscopic ablation therapy.Therefore, this stricture requiring treatment is likely related to the procedure.Patient responded well to treatment of stricture.No report of complications or sequelae.Device not returned; feedback analyzed.

Event Description

The patient was originally treated on (b)(6) 2017.Patient reported difficulty swallowing food and pills.Egd was done on (b)(6) 2017 - revealed stenosis.Dilated with through-the-scope (tts) balloon.Patient responded well to treatment of stricture.No report of complications or sequelae.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Type of Device: CRYOSURGICAL UNIT WITH ACCESSORIES,
• Manufacturer (Section D): C2 THERAPEUTICS; 303 convention way ste 1; redwood city CA 94036
• Manufacturer (Section G): C2 THERAPEUTICS; 303 convention way ste1; redwood city CA 94036
• Manufacturer Contact: florel malang ; 303 convention way ste 1; redwood city, CA 94036 ; 6505034750
• MDR Report Key: 6530549
• MDR Text Key: 73961223
• Report Number: 3008780134-2017-00007
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: FG 1012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention