MAUDE Adverse Event Report: CROSPON LTD ESOFLIP; ESOPHAGEAL DILATOR BALLOON WITH OR WITHOUT ELE

Model Number	ES-330
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was an esophageal perforation during the procedure.The catheter lost procedure, they deflated then inflated, but did not reach 20 milliliter, deflated again, and they noticed the perforation.

• Brand Name: ESOFLIP
• Common Device Name: ESOPHAGEAL DILATOR BALLOON WITH OR WITHOUT ELE
• Manufacturer (Section D): CROSPON LTD; galway business park, dangan; galway,fl H91P2 DK; EI H91P2DK
• MDR Report Key: 12440915
• Report Number: 3006897778-2021-00002
• Device Sequence Number: 3873332
• Product Code: PID
• UDI-Device Identifier: 05391530810043
• UDI-Public: 05391530810043
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: ES-330
• Device Catalogue Number: ES-330
• Device Lot Number: 20A1132JZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/08/2021
• 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: Other