MAUDE Adverse Event Report: CSA MEDICAL, INC. GEH; CRYOSURGICAL UNIT & ACCESSORIES

Model Number	20-00180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation (2001); Injury (2348)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a man approximately (b)(6) with barrett's esophagus with high- and low-grade dysplasia.He was treated initially with radiofrequency ablation but had persistent low-grade dysplasia just below the gastroesophageal junction.Upper endoscopy with liquid nitrogen spray cryotherapy was performed on (b)(6) 2019.A standard upper endoscope was used, and co2 insufflation was used throughout the procedure.After initial endoscopy was performed, a wire was passed and a 16 french orogastric decompression tube was placed uneventfully and taped to the patient's pillow.An active venting catheter was used.A nurse monitored the abdomen throughout the cryotherapy.The catheter and console functioned normally throughout the procedure, and the suction alarm was never triggered.A 20 second cryotherapy spray was performed uneventfully, and the tissue was allowed to thaw.After 10 seconds of the second spray, the patient's abdomen became very distended and cryotherapy was halted immediately.The cryode compression tube was removed, and no bends or kinks were noted.On repeat egd, the esophagus was normal, however a 2 cm perforation was noted in the posterior gastric cardia.Abdominal decompression was performed successfully with a paracentesis needle.Endoscopic suturing closed the perforation successfully, and the patient was admitted to the hospital with abdominal discomfort and treated with iv antibiotics.The following day, a gastrograffin upper gi series showed no leak.He was given a clear liquid diet the next evening and discharged on hospital day 4 without complication.

• Brand Name: GEH
• Common Device Name: CRYOSURGICAL UNIT & ACCESSORIES
• Manufacturer (Section D): CSA MEDICAL, INC.; usa; 91 hartwell road; MA 02421
• MDR Report Key: 9375070
• Report Number: 3010140265-2019-00007
• Device Sequence Number: 14219803
• Product Code: GEH
• UDI-Device Identifier: 00857068006082
• UDI-Public: 00857068006082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: 20-00180
• Device Catalogue Number: 20-00180
• Device Lot Number: 8515
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/26/2019
• 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
• Patient Age: 60 YR