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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophageal dilator with balloon and electrode sensors
Definition To dilate esophageal strictures with a dilating balloon and electrode sensors.
Product CodePIE
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
CROSPON LTD.
  SUBSTANTIALLY EQUIVALENT 1
CROSPON, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2019 6 6
2021 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 3 3
Product Quality Problem 2 2
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Esophagus 7 7
Radiation Exposure, Unintended 3 3
No Code Available 2 2
Chest Pain 2 2
Pain 2 2
Perforation 1 1
Vomiting 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Laceration(s) of Esophagus 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Pyrosis/Heartburn 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
Blood Loss 1 1
Abdominal Pain 1 1
Breast Cancer 1 1

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